FDA.reportPublic FDA data

Individual Free and Clear Foaming Antibacterial Skin Cleanser

Manufacturer
Ferguson Enterprises | Betco Corporation
Effective date
2024-06-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:36:58

Label at a glance#

ProductAntibacterial FoamSoap
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

Antibacterial skin cleanser Effective in destroying harful bacteria to prevent antibacterial cleansing

Dosage and administration

Read entire label before using this product. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 20 seconds and rinse with clean water.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w

Uses

INDICATIONS & USAGE SECTION

Antibacterial skin cleanser

Effective in destroying harful bacteria to prevent antibacterial cleansing

Warnings

WARNINGS SECTION

For external use only.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Read entire label before using this product.

Apply 5 milliliters (teaspoonful) or palmful to hands and forearms.

Scrub thoroughly for 20 seconds and rinse with clean water.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Citric Acid, FD&C Red 40, FD&C Yellow 5, Fragrance, Glycerin, Laurmine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium Glutamate Diacetate, Water

Purpose

OTC - PURPOSE SECTION

Antibacterial

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

751751

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN3
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD3
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY3
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84194-751-29Antibacterial FoamSoap1000 mL in 1 BAGSOAP10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84194-751ANTIBACTERIAL FOAMSOAP (BENZALKONIUM CHLORIDE) SOAP [FERGUSON ENTERPRISES]3Current NDC, 1 package rows20241115_18f9c948-74aa-ae19-e063-6294a90a23a1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84194-75184194-751-29

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ALOE VERA LEAFZY81Z83H0XIACT
FD&C RED NO. 40WZB9127XOAIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial FoamSoapBENZALKONIUM CHLORIDEFerguson Enterprises18f9c948-74aa-ae19-e063-6294a90a23a12024-06-24WarningsExact identifier
ndc (package): 84194-751-29
ndc (product): 84194-751
ndc11 (package): 84194075129
spl id: 1ba8c07f-ec45-7afb-e063-6294a90a9b24
spl set id: 18f9c948-74aa-ae19-e063-6294a90a23a1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.